VitalTraq for the Detection of CRS

NCT06415656 | Completed FDA Device

• 1 other identifier: Pro00115012
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• TempTraq's ability to measure axillary temperature in the intended use population.

  Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers.

  Day 14

Secondary Outcomes (5)

• Lead time by which fevers can be detected using TempTraq compared to SOC interval oral thermometer measurements.

  Day 14

• VitalTraq's ability to measure blood pressure in the intended use population.

  Day 14

• VitalTraq's ability to measure heart rate in the intended use population.

  Day 14

• Patient's perspective on the burden of using TempTraq and VitalTraq.

  Day 28

• Lead time by which TempTraq and VitalTraq can detect grade 2 or higher Cytokine Release Syndrome (CRS) as compared to the standard of care.

  Day 14

Study Arms (1)

Patients with hematologic malignancies

EXPERIMENTAL

Patients who are scheduled to receive CAR-T or BiTE through the Duke Adult Blood and Bone Marrow Transplant (ABMT) and Hematologic Malignancies Program.

Device: TempTraq; Device: VitalTraq

Interventions

TempTraq DEVICE

TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.

Patients with hematologic malignancies

VitalTraq DEVICE

VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.

Patients with hematologic malignancies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows:
• Axicabtagene ciloleucel
• Lisocabtagene maraleucel
• Brexucabtagene autoleucel
• Idecabtagene vicleucel
• Ciltacabtagene autoleucel
• Obecabtagene autoleucel
• Tisagenlecleucel
• Blinatumomab
• Mosunetuzumab
• Talquetamab
• Elranatamab
• Teclistamab
• Glofitamab
• Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening.

You may not qualify if:

• Receiving a non-FDA approved CAR-T or BiTE product
• Receiving Epcoritamab

Sponsors & Collaborators

• Duke University: lead
• Blue Spark Technologies: collaborator

Study Sites (1)

Duke Blood Cancer Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Chenyu Lin, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 16, 2024
• Study Start: October 13, 2024
• Primary Completion: June 15, 2025
• Study Completion: July 7, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)